Cellulite treatment system and methods

ABSTRACT

Systems and methods for treating cellulite including an apparatus that applies or a method involving separating septa to eliminate or reduce the appearance of cellulite. In one approach, an interventional tool is placed between tissue layers to engage and treat septa connecting tissue layers between which fat deposits are contained.

FIELD OF THE DISCLOSURE

The present disclosure generally relates to systems and methods fortreating cellulite. This application is a continuation of U.S. patentapplication Ser. No. 17/154,232, filed Jan. 21, 2021, which is acontinuation-in-part of PCT/US19/42871, filed Jul. 22, 2019 and claimsthe benefit and priority of United States Patent Application Nos.62/702,314 filed Jul. 23, 2018; 62/736,016 filed Sep. 25, 2018;62/798,515 filed Jan. 30, 2019; 62/802,368 filed Feb. 7, 2019; and62/825,447 filed Mar. 28, 2019, the entirety of the contents of whichare hereby incorporated by reference.

BACKGROUND OF THE DISCLOSURE

There is a continuing need for an effective approach to treatingcellulite, also known as gynoid lipodystrophy, nodular liposclerosis,edematofibrosclerotic panniculopathy, panniculosis, adiposis edematosa,demopanniculosis deformans or status protrusus cutis. Moreover, there isa need for proactive treatment modalities that prevent future orreoccurrence of cellulite and which are easy and effective to use.

It has been reported that more than 85% of women have cellulite thussuggesting that cellulite is a physiologic rather than pathologiccondition. The existence of fat in the reticular dermis alone is notthought to cause cellulite. Cellulite can be described as the herniationof subcutaneous fat within fibrous connective tissue that is expressedas dimpling of the skin. This fat loading can lead to stress onconnective tissue located between fat lobulas. Such dimpling is morecommon in women than men due to the orientation of subcutaneous fibrousstructures defining chambers containing fat cells. In fact, it is thisstructure that is believed to cause the appearance of cellulite morethan being overweight. Often, cellulite appears on the pelvic regionincluding the buttocks, lower limbs and abdomen.

Subdermal fat layers below the epidermis are contained between dermallayers connected by septa which act as connective tissue between thedermal layers. In men, the septa are arranged more randomly and denselyoriented in a more criss-crossed configuration while the septa in womenare generally more parallel in arrangement. Also, men have thickerdermis and more angled septa relative to the skin surface whereas womenhave relatively thinner dermis which thins with age, and septa that areperpendicular to the skin surface. Moreover, women with cellulite haveexhibited thickening of the septa in the regions of cellulite andtensioning of septa highlights cellulite. In women, fat storage inadipose tissue has a biological purpose in that it is maximized ensuringadequate caloric availability for pregnancy and lactation. An increasein fluid retention or proliferation of adipose tissue in such subdermalfat layers can further result in the appearance of cellulite where thesepta is maintaining a first distance between dermal layers, thuscreating dimples, whereas pockets between septa bulge. Over time, thesepta may stretch, then eventually contract and harden thus retainingtissue layers at fixed distances, but pockets between such septa may beexpanded thus adding to the appearance of cellulite.

Various approaches have been taken to treat or address cellulite. Earlytreatments involved attempts at increasing circulation and fat oxidationin areas exhibiting cellulite. Here, substances such as hyaluronic acidand aminophylline were injected in the target areas to reduce cellulite.Other approaches involved electroporating the target areas followed bythe application of mesotherapy, or applying dermological creams or othersupplements to cellulite. These approaches could be supplemented bymassage or massage was used alone for the purpose of promoting increasedfat reabsorption or drainage of fluids and toxins in the treated areas.Ultrasound has also been proposed to disrupt subcutaneous tissues andfat and has been used in combination with liposuction. Low acousticpressure in combination with the infiltration of microbubbles has alsobeen employed to reduce the appearance of cellulite, as has the use ofother energies such as lasers and radio frequency. Such approaches havebeen characterized by limited or unpredictable results. More recently,the cutting of septa with blades or needles in the subdermal region hasbeen employed. Prior approaches have been found to be labor intensiveand very traumatic to the tissue leading to bleeding, bruising, toughtissue nodules, long, painful recoveries and inconsistent results.

Accordingly, there is a need for effective and efficient approaches totreating, minimizing or eliminating cellulite with simple systems thatminimize trauma. These approaches should be associated with predictableresults and be relatively easy to employ.

The present disclosure addresses these and other needs.

SUMMARY OF THE DISCLOSURE

Briefly and in general terms, the present disclosure is directed towardscellulite treatment systems and methods involving an apparatus thatfacilitates and methods involving, depending on the system used andforce applied by the user, stretching, re-orienting, disrupting,cutting, slicing, and/or tearing septum or septa in a location ofcellulite. In one aspect, the treatment approach involves a tissuecutting or slicing system.

In one embodiment, a cellulite treatment device is mounted at a distalend portion of a shaft and is sized and shaped to be advanced betweentissue layers. In one particular aspect, fibrous septa that connectsuperior and inferior fascia plateaus within skin can be crossed withthe treatment device using one or more of an array of tools to engage,and depending on the tool used and force applied by the user, stretch,re-orient, tear, disrupt, cut or slice septa. By doing so, the targetsubcutaneous connective tissue associated with the surface defect can bedirectly modified with minimal impact to surrounding blood vessels andlymphatic system and fat can be more evenly distributed and skin canassume a smoother appearance.

In one or more aspects, a cellulite treatment system embodies a toolfacilitating an ability to reach and treat all target celluliteappearance areas through a single or a limited number of entries throughthe skin. In certain aspects, such tool is sized, shaped and configured(e.g. less than or equal to about two millimeters diameter and bluntdissection tip) to be placed within and advanced between tissue layerson its own and without assistance from external skin stabilizingstructure, such as a suction device. Entry points through the skin suchas high on the hip under where a bikini or underwear strap would be andalong creases or transitions between buttocks and thighs are employed.Identification and assessment of target septa is accomplished bypushing, pulling or otherwise tensioning septa in areas believed to beassociated with the expression of cellulite on the outside of skin. Ithas been recognized that septa causing a dimple or depression arelocated at various angles and locations relative to the dimple ordepression observed on the skin and are not necessarily directly belowsuch expressions of cellulite, and the treatment system and method isconfigured to identify the septa responsible for the appearance ofcellulite that has been marked on the skin and target treatment on thosesepta and leave adjacent septa, blood vessels, etc. intact. Moreover, arange such as a small subset or a larger number of septa can be thestructure causing a particular depression or dimple.

In one method, anesthetic is injected into the treatment sitetranscutaneously or subcutaneously, a cellulite treatment system isinserted subcutaneously across the treatment site and used to identifythe septa responsible for a depression or dimple by pushing or pullingon various septa to cause a depression in the skin in the target area,and a cutting or slicing device or septa disruption structure is placedsubcutaneously at the treatment site and employed to engage and cut orslice or break the septa tissue. In one particular aspect, the patientis directed to clench their buttocks and/or leg muscles to helpfacilitate identifying target areas and after septa treatment confirmrelease of septa that create dimples or depressions. Alternatively, thephysician can press in a cranial to caudal direction on the skin abovethe treatment target or pull from below the treatment target. Remoteimaging or ultrasonic or fluoroscopic energy can be employed to observethe procedure. A resizing or alternative configuration of the treatmentstructure can be employed to complete the treatment of a particulararea. The treatment device is then repositioned to treat additionalareas. The treatment device can be configured to treat a plurality ofareas simultaneously or in succession without removing from the patientor a spot treatment approach can be taken. Langer lines can be employedas a reference to direct treatment. Additionally, through one or moreentry points, various treatment trajectories are directed and in certainapplications a steerable introducer is used to access treatment areas.Further, anti-inflammatory, collagenase, deoxycholic acid, salicylicacid, glycolic acid, hyaluronic acid or cellulite treatment medicantscan be employed at the interventional site separately or directly by theinterventional device or other procedural instrumentation. Aspects ofthe current invention include specific identification of the septaresponsible for the cellulite appearance, severing or separation ofthose septa, confirmation intra-operatively of the separation of thosesepta was accomplished and the prevention of the re-appearance of thecellulite.

In various aspects, the treatment device can include one or more ofblunt tipped scissors, a guillotine-type angled blade, projectinglinkages, side opening hooks or V-shaped structure, an internal hook, abevel hook, a rotating structure or blade, a cutting balloon or harmonicscalpel, selective cautery structure or energy transmitting structurefor disrupting, cutting, slicing or dissecting tissue and/or controllingbleeding. In one particular approach, the treatment device includes amechanical septa cutting element, such as a blade or sharpened surface,that cooperates with a septa hooking element to both hook then cut,slice, tear or disrupt septa. One or more of the septa hooking elementand the septa cutting element is convertible from a hookingconfiguration to a cutting configuration and from a cuttingconfiguration to a hooking configuration or to a stored configuration.In another particular approach, the treatment device is embodied in anelongate member insertable through the skin capable of expanding atleast one region from a smaller state to a wider state, and when in thewider state is configurable to both hook and cut, slice or disrupttarget septa. In one or more alternative or additional aspects, cuttingor disruption is accomplished with electrical or thermal means such asmono-polar or bi-polar structures or a hot wire configured to addressbleeding and ease cutting.

The cellulite treatment system also involves in certain approaches,illumination such as a bright light configured at or emitted through atip of treatment structure or placed along or at strategic locationsalong treatment structure for the purposes of tracking advancement ofthe tool to the treatment site and locating intra-dermal structures atthe treatment site. In this way, direct observation of the treatmentdevice by transillumination through the skin is provided and positioningand performance thereof subcutaneously is readily available to anoperator.

Moreover, objective measurement devices are included in the treatmentsystem to assess the results of therapy. In one approach, laser lightenergy such as bright light or laser light is emitted and received bythe measurement device and surfaces of treated areas is scanned. Themeasurement device creates a complete three-dimensional map of allcellulite relative to normal skin. By comparing improvement of volume ofdivots versus normal idealized surfaces, the operator can calculatetotal and local volume benefits of therapy and track improvement overtime.

Additionally, the disclosed devices and structures are employed for bodysculpting, eliminating wrinkles, treating acne scars and/orrepositioning skin. Foam fillers or spacers of varying lengths and otherstructures such as subcutaneous attachment structures that areabsorbable or permanent are used to accomplish such objectives.

These and other features of the disclosure will become apparent to thosepersons skilled in the art upon reading the details of the systems andmethods as more fully described below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and B are perspective views, depicting cellulite on a subject'sskin and a plan for treating the cellulite.

FIG. 1C is a top view, depicting treatment across and along Langer linesof a subject lying on a treatment table.

FIG. 1D is a top view, depicting a cellulite treatment assembly andapproach for treating cellulite.

FIGS. 1E-N are partial cross-sectional views, depicting on embodiment oftreating septa below a skin surface.

FIGS. 10 -R are side views partially in cross-section, depicting analternative approach to transillumination.

FIGS. 2A-B are top views, depicting one embodiment of a scissor device.

FIGS. 3A-E are top views, depicting embodiments of hook and v-structurefor treating cellulite.

FIGS. 4A-B are top views, depicting treatment structure involving a hooktreatment structure.

FIGS. 5A-C are top views, depicting hook and slide approach to treatmentstructure.

FIGS. 6A-B are top views, depicting segmented treatment structure.

FIGS. 7A-N are top and partial cross-sectional views, depicting atreatment device with linkage hooking and cutting structure.

FIGS. 70 -P are isometric views, depicting one embodiment of a treatmentsystem and a treatment device.

FIG. 7Q-X are top and partial cross-sectional views, depicting furtherfeatures of a treatment device.

FIGS. 8A-C are perspective views, depicting components of a spottreatment system.

FIGS. 8D-K are side views, depicting additional approaches to treatmentstructure.

FIGS. 8L-V are cross-sectional views, depicting various treatmentapproaches involving a lasso.

FIG. 9A-B are cross-sectional views, depicting an atherectomy-typedevice and use thereof.

FIG. 10A-C are side views, depicting components of another treatmentsystem.

FIG. 11 is a side view, depicting components of yet another treatmentsystem.

FIGS. 12A-C are top views, depicting a further approach to a treatmentsystem.

FIGS. 13A-F are bottom and top views, depicting yet another furtherapproach to a treatment system.

FIGS. 14A-F are bottom and perspective views, depicting anotherembodiment of a treatment system.

FIGS. 15A-F are perspective and top views, depicting yet anotherembodiment of a treatment system.

FIGS. 16A-C are perspective views, depicting alternative or additionalfeatures of a treatment system.

FIGS. 17A-C are perspective views, depicting further features of atreatment system.

FIGS. 18A-C are perspective views, depicting yet further features of atreatment system.

FIGS. 19A-B are side views partially in cross-section, depictingalternative or additional features of a handle for a treatment system.

FIGS. 20A-F are side partial cross-sectional and top views, depicting afurther embodiment of a treatment system.

FIGS. 21A-C are side partial cross-sectional views, depicting anotherapproach to a handle assembly for a treatment system.

FIGS. 22A-C are side partial cross-sectional views, depicting yetanother approach to a handle assembly for a treatment system

DETAILED DESCRIPTION OF THE DISCLOSURE

Before the present systems and methods are described, it is to beunderstood that this disclosure is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present disclosure will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the disclosure. The upper and lower limits of these smallerranges may independently be included or excluded in the range, and eachrange where either, neither or both limits are included in the smallerranges is also encompassed within the disclosure, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present disclosure, the preferred methodsand materials are now described.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “thesystem” includes reference to one or more systems and equivalentsthereof known to those skilled in the art, and so forth.

With reference to FIGS. 1A-B, there is shown a person exhibitingcellulite 200 about their thighs and buttocks. In one approach totreatment, dimples and/or depressions characteristic of the cellulite200 intended to be treated are identified or circled with markings 204,preferably while the patient is standing as for most patients theappearance of their cellulite disappears when they lie down on theirstomach because gravity is pulling in a different direction. In anotherembodiment, computerized imaging equipment is used to locate and markdimples and/or depressions. In FIGS. 1A-B, forty-four dimples anddepressions are marked for possible treatment. The physician treatingthe patient determines an instrument insertion site 210 and paths 212that most efficiently treat cellulite with a minimal amount of insertionsites and instrument paths under the skin. Preferably, an instrumentinsertion site is chosen that is in a crease or fold of skin such aswhere the buttocks meets the thigh or in the crease between the twobuttocks at a location that is not seen when the buttocks are in naturalcontact for improved cosmesis after the procedure healing period. Incertain patients, the inner thigh is chosen as an insertion site as thislocation is less visual as it heals. Such treatment paths are selectedby the operator preferably using a straight edge that bends or contoursto the patient or can be generated automatically by employing acomputerized controller programmed to most efficiently address andmeasure cellulite residing in a pre-defined treatment site. Thecomputerized controller can be associated with a scanner that identifiesspecific dimples and areas for treatment such as by employing lasertechnology. In this regard, the computerized controller includes aprogram specific to cellulite treatment and is used in conjunction withan electronic and mechanical device and comprises or includes anon-transitory computer-readable storage medium and a computer-programmechanism embedded therein to both identify treatment areas and to plotprimary and alternative approaches to treatments. In another embodiment,computerized visualization and treatment planning equipment is used toassist the physician in determining insertion site locations and pathsto be taken to the marked targets.

Once a treatment approach is planned, the patient lies down on theirstomach on the treatment table. Alternatively, because of the minimallyinvasiveness of the current approach, a patient can be treated whilestanding, particularly for a small number of treatment targets, or whilestanding and leaning forward on a support and alternatively betweenstanding and leaning forward so that gravity can help identify andconfirm treatment of the targeted septa. Moreover, the measurementdevice creates a complete three-dimensional map of all celluliterelative to normal skin. By dating and comparing improvement of volumeof divots or dimples versus normal idealized surfaces, the operatorcalculates total and local volume benefits of therapy and trackimprovement over time.

In one specific approach, as shown in FIG. 1C, the cellulite treatmentfollows or references Langer lines 214 existing in tissue. Langer lines214 correspond to natural orientations of tissue fibers that exist inhumans, and have been recognized as being generally parallel to theorientation of muscle fibers. The Langer lines 214 can be used as areference to treat cellulite. Notably, cellulite appears to be relatedto and fall along the locations of Langer lines. In one approach,multiple treatment targets along Langer lines are treated from a singleentry 216, the Langer lines 214 providing a map along which treatment isaccomplished. Thus, treatment can be directed along Langer lines 214 asshown on the thigh for illustrative purposes to treat targeted septa, oradditionally or alternatively, treatment can be transverse to Langerlines 214 as shown on the buttock for illustrative purposes to treattargeted septa. Treatment can also be directed at various positionsabout connecting tissue or septa. That is, septa can be engaged,stretched, re-oriented, torn, cut, sliced, ruptured or disrupted fromvarious sides or angles respecting septa. Thus, septa can be treatedfrom above, below or the sides of septa to achieve the best results. Forexample, in a particular situation, treatment can be most effective fromabove a particular connecting tissue to take advantage of gravity wheretreatment forces placed on the connecting tissue coincide with thedirection of gravity or the direction that gravity most often works on astanding body, as it has been observed that cellulite is often mostvisible in a standing individual.

Turning now to FIG. 1D, there is shown a cellulite treatment assembly220 including a handle 222 and an elongate member or needle-sizedstructure preferably two millimeters or less in diameter, like structure224 extending longitudinally therefrom. A force gauge (electronic ormechanical) can be provided to ensure that a pre-determined amount offorce would be applied to the tissue when testing the septa to preventover or under pulling. A treatment device 225 capable of one or more ofengaging, stretching, slicing, cutting or disrupting connective tissueis configured at a distal end portion of the elongate member 224 (e.g.,FIGS. 1E-N). All cutting means can be combined with or further energizedwith RF, a laser, ultrasonic or thermal energy to produce cutting andcoagulation together or separately. In certain aspects, there can be asingle entry site or two entry sites, one high on the hip and anotheralong the crease or transition between the buttocks and thigh, or at theinner thigh. Such locations are characterized in that they can be easilyhidden either naturally or by clothing. Treatment targets, depressionsand dimples that have been marked on the skin surface while the patientis standing often go away when the patient lies down on their stomachbecause gravity acts on the skin and underlying connective tissue in adifferent direction such that the ink mark is apparent but the dimple ordepression is not. The disclosed interventional devices are configuredsuch that a user can approach a target location and first use theinterventional device to push, pull or otherwise tension septa in atarget area under the skin to identify the specific septa impacting thetarget and/or which is the cause of the expression of cellulite. Inother words, pulling or pushing on the septa under the skin to find theone(s) that create the dimple or depression in the skin surface. Forsome treatment targets, taking an approach from an entry locatedinferior the treatment target, advancing the end of the interventionaldevice beyond the treatment target and then pulling inferiorly(effectively the “down” direction if the patient was standing) canprovide a better approach, for example, for treatment targets on theleg, to re-create the dimple when the patient is lying down. One or morestrain gauges can be incorporated within the treatment device to helpidentify target septa as well as to assess the progress and completionof treating septa. This facilitates targeting of key septa in a lessimpactful way, ideally minimizing bruising or other issues associatedwith cutting or disrupting a large area around the target. There arethus herein shown various approaches to treating cellulite expressed asdimples or depressions 200 in the skin surface. Moreover, the handleportion can be employed to create an indentation in skin through whichinterventional devices can be inserted subcutaneously. A treatmentregimen is selected for inserting interventional instruments based uponthe subject's anatomy as it relates to the septa 350 connecting tissuelayers that define the chambers retaining fatty or other tissues. Ifdesired, while anesthetic and/or sedation is taking effect, ultrasoundcan be used to assess the subcutaneous trajectory and depth of thevarious connective tissue bands responsible for the surface unevenness.The ultrasound evaluation can help with the particular trajectoryselected for the desired depth. The ultrasound evaluation can also helpwith positioning the distal end portion of the treatment instrumentstrategically at the connection point between the connective tissue andthe dermis or the facia.

As shown in FIG. 1E, targeted locations of cellulite 200 to be treatedare marked 204 on the surface of the skin. This can be done when thepatient is standing to best see cellulite. As shown schematically inFIG. 1F, cellulite can diminish or disappear when an individual islaying down, and should this happen, the marks identify and confirmtheir locations.

In one aspect, a distal end portion of a cellulite treatment assembly220 is inserted through the skin and the blunt tip is guided up intoclose proximity of the dermis as the tip can be tracked as it isadvanced toward septa 350 (FIG. 1G) near the marked location 204. Theinventors have discovered given the elasticity of septa 350, thedistance from the marked location 204 to where the treatment assembly220 is inserted into the skin is preferably at least about 2 cm so thatthere is enough distance to pull and disrupt septa 350 and not have thetip of the cellulite treatment assembly exit the skin in the process.Additionally, a depth below the skin where septa 350 is preferablyengaged (i.e., cut, sliced, torn, stretched, re-oriented (e.g.criss-crossing) or disrupted) is identified and determined. Afterdetermining the subcutaneous depth to be accessed for the cutting,slicing, tearing, stretching, re-orienting (e.g. criss-crossing) ordisrupting of septum 350, the cellulite treatment assembly or other toolwith a sharpened or blunt tip is inserted through the skin, advancedbetween subcutaneous tissue layers and toward septa 350. In oneapproach, a distal end portion of the cellulite treatment assembly isconfigured with an illuminated tip 352 with enough brightness to be seenthrough the skin. The intensity of light emitted by the tip 352 can beset to a specific constant level such that at the preferred depth belowthe skin for severing or otherwise engaging septa 350, the light thatappears at the level of the skin as a circle or projection is of apre-determined size. Thus, the treatment device is advanced to thetarget site. At the target site, the user adjusts the depth of the tipof the treatment tool such that the circle or projection of light is thepre-determined size. The septa 350 is tested and if confirmed as atarget for treatment, the septa 350 is treated while maintaining thecircle or projection at the pre-determined size. The user can also usethe size of the circle or projection of light to maintain the depth ofthe tip of the treatment tool as it is advanced under the skin to thetreatment target. In an alternative or another aspect, a sharpened tipis employed to create access to target tissue thus allowing the tool tocreate the desired path both into tissue as well as between tissuelayers. It is expected that the depth that these tools are advanced willbe between about 3 and about 10 mm below the skin surface, but it isanticipated that lesser and greater depths may also be optimal for aparticular subject. In any event, the depth selected is chosen forcutting, slicing, disrupting, tearing, stretching or re-orienting of thesubject's septa 350. Moreover, in one embodiment, it is to beappreciated that the device 220 is formed from a substantially rigidmaterial so that a consistent plane below the skin surface is accessed.

Using palpation, direct visualization (for example, transillumination orendoscopic) or non-invasive visualization (for example, ultrasound orfluoroscopic) or other means for determining the position of theinterventional tool such as markings along the length of the instrumentsand its path within tissue, or providing the interventionalinstrumentation with radiopaque markers, the tool is placed at a sitebelow where cellulite (for example a dimple) is seen on the subject'sskin. The treatment device is advanced through septa 350 and to wherethe treatment device 225 is in a position best suited to accomplish theidentification of target septa and the cellulite removal or minimizationtreatment. As shown in FIGS. 1H-J, in one approach, the treatment device225 is passed beyond septa 350, a hook is deployed and then pulledproximally to tension septa 350, such as by hooking the septa (FIG. 1K).In another approach, the treatment device 225 is passed a fewmillimeters lateral, preferably about 1 to about 10 millimeters, morepreferably about 3 to about 6 millimeters, and beyond the targetlocation, a hook is deployed and then swept laterally toward the targetfollowed by pulling proximally to hook and tension septa. During theseand other steps, transillumination can be employed to track thetreatment device and guide the procedure. The marks 204 can facilitatetargeting of septa 350 while using transillumination to see the locationof the treatment device 225. In other approaches, a separate device canbe employed to engage septa 350 to see if such septa are the source of adimple or depression expressed on the outside of the skin. Such asecondary device can be placed remotely from the target (i.e. lesion)and configured to be capable of applying tension to the surface of skinin a predetermined direction so as to create the effect of gravity andproduce the visualization of the lesions while the patient is in a proneposition (i.e. a broad region of adhesive attached to a spring mechanismsuch that a predetermined force would be applied relatively parallel tothe surface of the skin in the direction the skin would move whenstanding in gravity). Using this additional device could further helpthe confirmation and location of lesions and allow confirmation that thetreatment was effective. Also, in various approaches, a portion of theelongate member can be configured to transition from a smaller state toa wider or larger state, wherein in the wider or larger state a cuttingsurface (i.e. sharpened edge or energy) is presented to cut tissue, thedevice being sized and shaped to be inserted through the skin and engageone or more regions of septa subcutaneously.

It is noted that septa causing a dimple or depression may be coming fromvarious angles and locations relative to the dimple or depression seenon the skin rather than being directly below the dimple or depression,and may be due to one or only a few septa or a large number of septathat remotely cause the depression or dimple. Thus, so engaging certainsepta will be reflected in some change in the dimple or depression onthe skin. A determination is made concerning the correspondence withmarks 204 made on the skin and the dimples being formed or re-formed. Ifthe initial septa 350 that the user presses on or pulls on using thetool do not recreate a dimple or depression in the marked area 204, thenthe user releases those initial septa that were engaged and repositionsthe tool at different septa and presses on or pulls again. This isrepeated until the septa responsible for a dimple or depression in themarked location are identified (FIG. 1K). Once proper septa areidentified, the tool 225 is manipulated to cut, slice, disrupt,re-orient, stretch or tear septum 350 connecting tissue layers. In oneapproach, a blade 353 is deployed and presented for treatment (FIG. 1L).In another approach, a balloon (not shown) is inflated to disrupt thesepta.

After the proper septa have been cut, sliced, disrupted, stretched,re-oriented or torn, the treatment element 225 is moved back to itsinitial collapsed configuration. The treatment element is then advancedbeyond the marked treatment location, the treatment element (e.g., hook)is deployed and then pulled back under the marked treatment location toconfirm that all of the septa responsible for causing the marked dimpleor depression have been separated intra-operatively. If they have notbeen, the tool is manipulated to cut, slice, disrupt, stretch, re-orientor tear additional septa. The steps are repeated until all of the septaresponsible for creating the marked dimple or depression have beensevered or sufficiently stretched and the dimple or depression cannot bere-created intra-operatively using the tool. Such manipulation resultsin selective rupture, tearing, cutting or slicing of targeted septum350, and the removal or minimization of dimples and the expression ofcellulite on skin (FIG. 1M). Thereafter, the treatment element (e.g.,hook and/or blade) is retracted back in (FIG. 1N partially collapsed)and the tool 220 is removed from the site to be withdrawn from the bodyor repositioned in any direction along and within the target tissueplane to treat additional areas.

With reference to FIGS. 10 -R, in additional or alternative approaches,a second light source 354 such as an LED (or other light source) isconfigured along the cellulite treatment assembly 220 proximal theilluminated tip 352 or alternatively, at the tip 352. In variousapproaches, a light source such as an LED chip can be configured at thetip of or otherwise along the treatment device with an electrical wirerunning proximally for control by the operator, or the light source canbe generated by a light fiber extending along the device or to the tipwith the LED or light source is configured within a proximally locatedposition such as a handle of the treatment device. By so configuringsuch light sources 352, 354, the depth of the cellulite treatmentassembly 220 within tissue can be assessed. As shown in FIGS. 10 -P,when the cellulite treatment assembly 220 is placed within a firstrelatively shallow desired depth, the light sources 352, 354 appearspaced and define discrete patterns when viewing the light sources viatransillumination through skin (FIG. 1P). When the cellulite treatmentassembly 220 is placed deeper within tissue (FIGS. 1Q-R), the lightsources 352, 354 overlap (FIG. 1R) due to the natural dispersion oflight emitted from the light sources 352, 354. An operator of thetreatment system can determine a depth of the cellulite treatmentassembly 229 by noting the discrete patterns of light or the degree ofoverlap of light overlap, the dispersion of light emitted and intensityof the light emitted from the light sources 352, 354. Thus, allowing theoperator to guide the distal end of the treatment assembly to thedesired treatment location while maintaining the desired depth below theskin. The light sources 352, 354 can also be of a different color to aidin determining the orientation of the cellulite treatment system 220within tissue through illumination. Moreover, the second light source354 can emit a red color, for example, while the illuminated tip 352 canemit white light, while noting any variation of colors can also beemployed. Also, the color of the light can change depending on theconfiguration of the treatment device, such as for example, the devicecan project a white or first color when sheathed or stowed and change toanother color or second color when a portion of the device is deployedor before and after use such as when tissue is cut. A strain gauge canbe configured to communicate and cooperate with the light source tosense loads placed on the treatment device during treatment to therebyfacilitate a change in color of the light source and to signal theprogress or completion of targeted treatment. Additionally, the secondlight source 354 can be employed via transillumination through skin tolocate the cellulite treatment system relative to a treatment targetarea. Another benefit of the second light source is that it can indicateto the user where the hook and blade are located relative to the targetsepta. Also, as the treatment tool is being pulled proximally throughthe treatment target area, the illuminated tip 352 lets the user knowwhen the hook and blade have been pulled through the target area. It isfurther noted that the light sources 352, 354 can be positioned atvarious alternative locations along a treatment device, and can bespaced from each other by various amounts. That is, a proximallypositioned light source provides light proximal of the hook and blade ofthe treatment system, the same aiding the operator to assess and/orengage all septa at a target site. The operator can thus position thecenter of the light projected from the proximally positioned lightsource under and/or beyond the treatment target area to help ensure thatthe hook and blade of a treatment device, for example, deploys beyondthe anticipated location of the target septa so that when the device ispulled proximally the hook or other tissue engaging structure of thetreatment device encounters the target septa thus replicating thedepression. Also, the cellulite treatment system can include greaterthan two light sources of the same or dissimilar colors. In anotherembodiment, different colors of light can be used to indicate that thestate of the distal end of the instrument. For example, red light isused to indicate the hook and blade are inside the instrument foradvancing under the skin, white light is then used to indicate the hookis deployed, and red light is then used to indicate when the blade isdeployed.

After completing treatment of one target area, the procedure is repeatedto treat other target areas. Accordingly, the same device can beemployed to access tissue layers below other sites or depressionsexisting in skin. Notably, in one embodiment, the device is capable ofanesthetic delivery as needed or desired when progressing to additionalor new locations. There is thus provided a system configured to treatall target areas on the buttocks and thigh through a limited number ofsmall entry sites, including through a single entry site. It is to berecognized that the system can further include structure permitting theassembly to be steerable to subcutaneous treatment sites. In such anembodiment, the device would be configured to define longitudinallyflexible material, and the instrumentation would be steered to thedesired position within tissue. Moreover, in certain applications, thedevice has a stiffness that varies along its length. In anotherembodiment, the treatment device is embodied in a deflectable catheter.

Moreover, in certain embodiments, the cellulite treatment systemincludes a squeezing tool that reproducibly applies lateral forces onthe skin to emphasize the dimple or expression of cellulite so a beforeand after treatment effect can be obtained without requiring the patientto stand up and/or without having to remove the interventional tools.The squeezing tool can be embodied, for example, in a clamp withelongated feet on opposite sides thereof or includes four fingers thatpull radially inward once deployed on the surface of the skin andactivated over or adjacent the targeted cellulite region. Further, thepatient is directed to clench their buttocks and/or leg muscles whilelying on the procedure table or while standing to both identifytreatment sites as well as confirm treatment. In another embodiment, askin stabilizer, such as a suction stabilizer, can be used to helpcontrol the depth at which the cellulite treatment tool is advancedunder the skin and maintain the targeted location as the tool isadvanced.

With respect to FIGS. 2A-B, there are shown blunt tipped scissors 360that are configured at a distal end portion of a cellulite treatmentassembly 220. The blunt tipped scissors 360 are advanced under the skinto a target and used to engage suspected septa. As in each of thedisclosed approaches and apparatus, should engagement of such septaresult in some change in the dimple or depression expressed on the skin,the treatment structure, here scissors 360, are manipulated to disrupt,cut or slice the septa. Thus, the scissors 360 are opened and septa isplaced between its blades. Next, the blades are advanced against orcaused to be closed about the septa to thereby cut, slice or sever thesepta, thus relieving the tension between tissue layers and eliminatingor minimizing the appearance of the dimple or depression expression onthe skin. Actuation of the scissors is accomplished from a proximal endof the treatment device such as by pulling a wire or advancing andpushing an elongate member associated with the scissor arrangement (notshown). Illumination can be provided by a light 362 configured proximalof the scissors 360 so that transillumination can be employed to trackthe location of the distal portion of the treatment assembly 220.Additionally, or alternatively, in each disclosed embodiment,illumination can be via a lightguide from an external light source orvia one or more LEDs. Illumination aids the user both with locating thetreatment device as well as proper depth placement as transilluminationdecreases with increasing tool depth. In one aspect, the amount ofillumination is set to ensure proper depth of a treatment device orstructure, the level of illumination targeted being adjusted for skintype, thickness, presence of fat and pigment. Once selected or targetedsepta are cut, sliced or disrupted, in each of the disclosed approaches,the cellulite treatment device can be or is advanced or repositioned totreat additional target areas from the same or different skin insertiondevice.

Various approaches to laterally projectable tissue engaging and/orcutting structure are shown in FIGS. 3A-E. The distal end portion of thecellulite treatment assembly can embody a side opening hook arm 370 thatrotates with respect to a longitudinal shaft 372 to alternativelydisplay septa engaging and/or septa cutting structure (FIGS. 3A-B). Thehook arm 370 is configured to swing out from a proximally directed,longitudinal configuration where it is parallel with the shaft 372 to alaterally projected configuration to thereby capture and tension septaonce the device is advanced beyond the target location and thenretracted. Here again, so engaging septa can confirm that the septaresponsible for creating skin surface dimples or depressions is beingtargeted as such engagement with septa will be reflected in a physicalchange of the skin surface. Disruption results from tensioning septaagainst a narrow edge of the hook arm 370 or against a cutting orsharpened edge thereof. An outward facing portion of the arm 370 candefine blunt structure and a cutting edge can be positioned within theacute angle defined by the arm 370. With this structure, increasedtension can be employed to cooperate with a limited cutting edge assepta is drawn within the acute angle defined by the arm 370. In FIGS.3A-B, transillumination functionality is provided by a light 376configured at a terminal end of the device, whereas in the assemblyshown in FIGS. 3C-D, slits 378 formed in the shaft proximal the terminalend allow for the dispersion of light energy. In FIG. 3E, cutting andsepta engaging structure is embodied in a single moving arm 380, whileillumination is provided proximal a hinge 382, but the same can bepositioned at the terminal end of the device. As in the previousembodiments, the exposed edges of the arm 380 can be blunt or sharp forcutting or slicing. Also, here, the arm 380 assumes a distally directed,longitudinal configuration parallel to the shaft 372 for advancementbetween tissue layers, and the arm 380 is caused to be projectedlaterally outwardly to both capture and cut or slice target septa.Actuation of the engaging and cutting structures can be accomplishedthrough the manipulation of a proximally positioned lever or triggerconnected to the same via a wire or longitudinally directed shaft (notshown). Once a desired area is treated, additional target areas can beaddressed.

The distal end portion of the cellulite treatment assembly 220 canalternatively or additionally embody an internal static hook 388 (FIG.4A) to treat target areas from one or more skin insertion sites. Aterminal end of the assembly or the hook itself 388 can be employed tobe placed about tissue and to engage and test tissue to identify targetsepta. Sharpened edges within the hook can be used to engage and cutsepta that has been targeted and identified as being associated with theexpression of cellulite on the skin. As shown in FIG. 4B, a concentricsliding tube 390 actuatable from a proximal end of the cellulitetreatment assembly can additionally be provided to be moved proximallyand distally with respect to a hook 392. The tube 390 can includeselectively sharpened edges or can be blunt to thus cooperate with thehook 392 to capture, cut, slice, tear or disrupt septa. The assembly canfurther be advanced in a spinning manner to cut or slice through septa.Employing the tube 390 to cut tissue results in a section being takenout of the septa as spaced cuts are simultaneous made through the septa.

As shown in FIGS. 5A-C, in a related approach to treating multipletreatment sites, a cutting, slicing or disrupting assembly additionallyor alternatively includes a longitudinally extendable and retractablesheath 393 that alternatively covers and exposes a hook 392, and furtherembodies an extendable and retractable guillotine-like blade 394. Theblade 394 is sized and shaped to slide within an opening defined by thehook 392 and to cut tissues snared by the hook 392. Thus, in its distalposition, the sheath 393 facilitates the assembly to define structuresuited for advancement to a treatment site. Withdrawing the sheath 393through manipulation of structure connected thereto positioned at aproximal end of the assembly, exposes the hook structure 392. The hook392 is used to engage and capture target tissue to test if the targetedtissue is associated with the expression of cellulite on the skin. Whilethe hook maintains the septa in a captured position, the guillotineblade 394 is advanced through manipulation of a proximally positionedactuator (not shown) to slice or cut captured septa to thereby eliminateor minimize the appearance of cellulite.

Turning now to FIGS. 6A-B, there is shown yet another approach to adistal end portion of a cellulite treatment system 220. Here, atwo-segment hook assembly 396, 397 is held together with a tensioningforce (such as a spring or a wire or shaft connected thereto) on angledsurfaces 398. When one segment is turned relative to the other, an angleis formed between the two segments. It is to be recognized that thelength of this hooked structure can be adjusted to fit a particularneed. Further, selected edges of the hook assembly can be sharpened orbe blunt. In one particular aspect that applies to each of the disclosedembodiments, the hook can be covered in an elastomer such that as theelastomer is tensioned, the elastomer is displaced thus exposing thesharpened edges. When untensioned, the sharpened edges are safelyencased. In another approach, a spring-loaded shield can replace theelastomer. Manipulation of the two-segment hook assembly 396, 397 withintissue and between tissue layers allows for both the engagement andidentification of target septa as described herein, as well as theslicing, cutting or disruption of targeted septa.

Referring now to FIGS. 7A-D, a cutting, slicing or disrupting treatmentassembly is defined by a projecting linkage arrangement. A first link400 includes a blade 401 and is rotatably attached at one end to asecond link 402. The opposite end of the first link 400 slides withrespect to a longitudinal shaft 405. A second end of the second link 402is rotationally affixed to a distal point on the shaft 405. In oneembodiment, as a drive shaft 407 attached to the opposite end of thefirst link 400 is advanced, the links 400, 402 fully overlap (FIG. 7C)to create a hook arrangement sized and shaped to engage tissues and totest septa to determine if such septa is associated with the expressionof cellulite on a patient's skin. In this arrangement, the bladestructure 401 is not exposed, but rather it is protected or covered bythe second link 402. When cutting or slicing action is desired, such asonce selected septa are targeted, the drive shaft 407 is slightlyretracted, thereby exposing the blade structure 401 to thereby present asharp edge for cutting of hooked septa (See FIG. 7D). To store the links400, 402 away for advancement or repositioning between tissue layers,the shaft 407 is withdrawn completely which results in the links 400,402 assuming a co-linear and parallel relationship with the shaft.

In a related approach, as shown in FIGS. 7E-G, the first link 400defines a curved blade that is rotatably connected to a second link 402that includes a generally triangular or pointed projection 408 that issized and shaped to cover the blade 401 when the assembly is placed in ahooking configuration (See FIG. 7F). When the drive shaft 407 (shown inphantom lines) is manipulated such that the blade 401 is exposed (SeeFIG. 7G), the blade 401 can be employed to cut septa. When advancing thetreatment device to and between interventional sites, the drive shaft407 is withdrawn so that the assembly defines a lower profile where thefirst 400 and second links 402 are generally longitudinally aligned(FIG. 7E). As shown in FIGS. 7H-K, the rotatable connection between thefirst 400 and second links 402 can additionally or alternatively becharacterized by a slotted arrangement 409. With such a connection, theprojection 408 can be smaller, thus resulting in the overall profile ofthe treatment device being smaller. Notably, in a septa hookingconfiguration (FIG. 7J) after pulling the drive shaft 407 proximallyslightly, an end of the first link 400 resides in a proximal positionwithin the slot 409 and the smaller projection 408 of the second link402 overlays the blade 401. In a septa cutting configuration (FIG. 7K),the end of the first link 400 assumes a distal position within the slot409 such that the blade 401 is exposed for cutting. With reference toFIGS. 7L-N, in another embodiment, the first link 400 can also define astraight blade 401. In this approach, the projection 408 is larger totherefore provide necessary coverage of the blade 401 when the device isplaced in a hooking configuration (FIG. 7M). Each of the foregoingdevices can also additionally or alternatively include other of thefeatures disclosed herein such as structure providing transilluminationand radiofrequency cutting and coagulation.

Referring to FIGS. 70 -P, there is shown one embodiment of a cellulitetreatment system 940 (described in more detail in connection with FIG.11 ) that can be employed to treat cellulite. As shown (FIG. 70 ), adistal end portion of the treatment system 940 is configured with atreatment device 925. Here, the treatment device of FIGS. 7L-N is shownpositioned at the distal end of the treatment device 940 in a hookingconfiguration (FIG. 7P). Any of the disclosed treatment devices can beso configured at the distal end of the treatment system 940.

As shown in FIGS. 7Q-S, the treatment device can alternatively oradditionally include a wire 410 that is rotatably attached to the secondlink 402. Here, a proximal portion of the wire 410 serves as structurethat can be advanced and retracted to configure the treatment deviceinto closed, hooking and cutting positions. Further, the wire 410 isformed into a coil 411 (See FIG. 7S) that provides necessary strengthand robustness for moving the wire 410 between closed (FIG. 7Q) andcutting (FIG. 7S) configurations. In a septa hooking configuration (FIG.7R), the second link 402 covers the wire 410 thereby prohibiting thewire to be exposed to target septa, and the coil 411 aligns with thesecond blade 402. In its closed configuration (FIG. 7Q), the treatmentdevice defines a low profile suited for being advanced to and betweentreatment targets. The proximally facing edge of the wire can besharpened to produce a cutting edge. In addition, or alternatively, thewire can be an electrode attached to a radiofrequency generator so thatthe wire can be used for electrocautery or RF cutting of target tissue.

In other alternative or additional aspects, the elongate member 224 of acellulite treatment device, as shown in FIGS. 7T-U, can embody a tubularshape, including a lumen 412 extending therethrough, the lumen providinga space for a light fiber 414. Notably, the remaining space not occupiedby the light fiber 414 defines a crescent moon shape from across-sectional view perspective. In one approach, the tubular portionterminates at the treatment device 225.

As shown in FIGS. 7V-X, again in one or more embodiments, the lumen 412of the elongate member 224 can be sized and shaped to individuallyreceive one or more additional septa engaging, cutting, slicing ordisrupting treatments devices 225 or for the injection of anesthetic,medications or other substances such as fillers or fat transfers before,during or after treatment. In one approach, a treatment site can bedosed or filled with material contemporary with or during a treatmentprocedure rather than using a separate device and procedure toaccomplish the same. Notably, each of the disclosed embodiments can becombined to provide a combination cellulite treatment assembly in asimilar manner.

In an alternative embodiment, spot treatment of septa is possibleemploying a cellulite treatment system 800 configured to address oneinterventional site at a time. Thus, cutting structures can be insertedperpendicular to skin to accomplish treatment or can be advanced belowthe skin in a direction generally parallel to the surface of the skin orangles with respect thereto. Moreover, the structures of each of thedisclosed tissue engaging and cutting devices can alternatively oradditionally be configured to be used for treatment. In one particularaspect, the cutting action is rotary in character, such that cutterstructure spins with controlled speeds configured to cut septa in amanner dictated by observed septa structure at the interventional site.The cutter is alternatively or additionally configured to accomplishcutting action by engaging or dragging the cutter against target septa.Again, here, the degree to which the dragging is performed is dictatedby the septa and septa inherent structure. In one approach, a system 800includes an elongate handle 802 that is provided for grasping by anoperator (See FIGS. 8A-C). Extending longitudinally from the handle 802is a needle assembly 804. The needle 804 is configured to create aninsertion site adjacent a specific cellulite target area, or directlyinto a dimple cellulite site. Further, it is through the needle assembly804 that interventional site instrumentation is advanced to address andtreat septa residing below a dimple expression on a subject's skin.Additionally, in one embodiment, a dilator can include or cooperate witha harmonic scalpel, selective cautery structure or energy transmittingstructure for dissecting tissue and/or controlling bleeding. In oneapproach, once a correct depth is accessed, a cutting instrument isswept 360 degrees to cut surrounding septa. Additionally oralternatively, an endoscope can be employed in an assembly including acutter to sever septa in a targeted manner. That is, septa that areviewed by the endoscope are targeted for severing by the cutter. Here,direct visual confirmation of a treatment is provided.

In one embodiment, the needle 804 can be fashioned with a stop 810 thatis positionable along the needle 804 as desired or dictated by aparticular procedure or anatomy. The stop 810 is located so that whenthe needle 804 is placed within tissue, its terminal end is positionedat a desired depth such as between tissue layers connected by septa. Aside opening 822 is further provided at the terminal end of the needle804. It is through this side opening 822 that interventional devicessuch as cutters, scalpels, cautery structure or energy transmittingdevices are advanced between tissue layers. Such devices are thenemployed to selectively treat the septa residing below the skin for thepurpose of eliminating or reducing the appearance of cellulite. Once itis determined that the treatment has been successful, the spot cellulitetreatment system 800 is then removed and employed at another locationexhibiting cellulite.

Turning now to FIGS. 8D-J, there are shown further aspects of toolsemployed for treatment of cellulite in alternative approaches. Suchstructure can also be employed as distal end structure for the cellulitetreatment assembly shown in FIG. 1D. With reference now to FIG. 8D, atreatment device can be equipped with a wire that includes linkages 830manipulation of which function to push out a cutting blade 831arrangement that is sized and shaped to cut connective tissue. As shownin FIG. 8E, a distal end portion of a spot treatment device can beequipped with a wire arranged to be advanceable to define a loop 832,the loop having a gauge facilitating the structure to be employed to cuttissue. Alternatively, RF energy can be employed to cut septa. FIGS.8F-G depicts a deformable hypotube 834 that is expandable such that twoor more arms 836 project to define blades for cutting in anothernon-atraumatic approach to treatment. FIG. 8H illustrates a balloonstructure 840 attached to a needle hypotube 842 which can be expandedbelow a dimple to eliminate or reduce the appearance of cellulite.Finally, in another non-atraumatic approach (FIG. 8I-J), a distal endportion of a spot treatment device can be fashioned with blades 850, oneto cut for deployment and at least one that is configured to rotate andcut connective tissue.

As shown in FIG. 8K, a dilator 410 can form a distal end portion of acellulite treatment device and additionally be equipped withlongitudinally extending blades 853 that are deployed when the dilator410 is expanded. The blades 853 are configured to engage and cut targettissue or septa in an alternative approach to treatment. Such cutting isemployed in an alternative to a non-traumatic approach and accomplishedby rotating or otherwise advancing, sweeping or retracting the dilator410. The assembly is unexpanded and withdrawn from the interventionalsite after use such as through a tube.

In yet another treatment approach, a curved wire forming a lasso 859 andforming a distal end portion of a cellulite treatment assembly and beingadvanceable and retractable through a shaft 861 (FIGS. 8L-O) can bedeployed about septa 350 within a target zone. Pulling the lasso 859 toreduce the perimeter it defines results in cutting septa 350 andtreating cellulite. In one aspect, the lasso is formed from nitinolwire, or is pre-formed wire or pieces thereof. The lasso 859 encirclestargeted septa and via tightening, cuts the septa. One approach involvescutting a targeted area without shaft movement thus providing acontrolled approach to treatment.

As shown in FIGS. 8P-T, the lasso 859 can additionally or alternativelydefine a tube and the assembly can additionally include a wire 863 thatis slidably configured within the tubular structure. After septa 350 istargeted, the lasso structure 859 is partially configured about thesepta 350 by pushing it out of shaft 861. The wire 863 is then advancedwithin the lasso 859 and out of a terminal end of the lasso 859 (FIG.8Q). The wire 863 is then advanced toward a slot or opening 865 formedin the shaft 861 and is retained therein. Thereafter, the lasso 859 isfurther advanced to and into engagement with the shaft 861 to therebydefine a completed hoop or loop (FIG. 8R). The lasso 859 is then pulledtight about the target septa 350 to cut, slice or disrupt the septa asdesired (FIG. 8T). Alternatively, the completed hoop can remain in itslarger hooped configuration and the entire device can be pulledproximally to slice or disrupt the encircled septa. After treating thetarget tissue, the lasso 859 and wire 863 are pulled proximally throughthe shaft 861 so that they disengage from the slot 865 and are withdrawncompletely or partially within the shaft 861 so that the treatmentdevice can be used in additional locations.

In a related lasso treatment approach (FIGS. 8U-V), there are provided apair of elongate tubes 867, 868 configurable in a generally parallelarrangement about target septa 350. The lasso 859 is advanced within thefirst tube 867 and out a terminal end thereof and toward the second tube868 (FIG. 8U). The lasso 859 is then captured by the second tube 868 sothat the treatment device encircles target septa 350. The assembly isthen pulled proximally to cut, slice or disrupt target tissue. Aftertreatment, the lasso 859 is withdrawn within the first tube 867 andreleased from engagement with the second tube 868. The assembly is thenpositioned as necessary to treat additional areas.

An atherectomy-style cutter 902 (See FIGS. 9A-B) also can bealternatively or additionally configured to remove tissue through anopening 904 on the side of the instrument, can be used in certainancillary, more traumatic approaches to treatment. Cutting structure 906is attached to an elongate actuator 908 via a block or other connection910. Manipulation of the actuator 908 causes the cutting structure 906to engage targeted tissue. A lumen 912 is further provided as a conduitfor applying a suction force to the interventional site so that severedor macerated tissue 912 can be removed. This device can be employed toharvest fat for subsequent placement at a site that has been treatedwith a dilator and used to fill the space created. The cutter 902 canalso be employed as a primary treatment device for cutting septa totreat cellulite.

Turning now to FIGS. 10A-C, there is shown one preferred embodiment of atreatment system 920 that can be used in connection with one or more ofthe previously described devices for treating target tissue. Thetreatment system 920 includes a handle 922 and an elongate member 924extending longitudinally from the handle 922. As described above, aforce gauge or sensor (electronic or mechanical) can be provided toensure that a pre-determined amount of force would be applied to thetissue when testing the septa to prevent over or under pulling.Moreover, a treatment device 925 capable of one or more of engaging,slicing, cutting or disrupting connective tissue is configured at adistal end portion of the elongate member 924. Thus, any one or more ofthe treatment devices described herein can define the treatment device925. All cutting means can be combined with or further energized withRF, a laser, ultrasonic or thermal energy to produce cutting andcoagulation together or separately.

The handle 922 is equipped with a button or sliding trigger 926 that isconfigured to slide along a top surface of the handle 922. The trigger926 is attached to a proximal end portion of a shaft or wire 928, adistal end portion of which is associated with or attached to thetreatment device 925. In a closed configuration, the trigger 926 ispositioned in its most proximal position (FIG. 10A), and the treatmentdevice 925 maintains a generally longitudinally aligned configuration.As so configured, the treatment system 920 can be positioned orre-positioned to accomplish desired cellulite treatments. Moving thetrigger 926 to its most distal position in turn causes the shaft or wire928 to advance distally and place the treatment device 925, for example,in a configuration for hooking target tissue (FIG. 10B). Withdrawing thetrigger 926 to an intermediate position, exposes a cutting structure(such as a blade or cutting wire) to thereby configure the treatmentdevice 925 for cutting, slicing or disrupting target tissue (FIG. 10C).Detents or other cooperating structure can be incorporated into thehandle or trigger to secure the trigger in one or more positions as wellas to provide a tactile feedback regarding positioning. Further, thesystem 925 can alternatively or additionally include any of thepreviously described functionality such as structure for providingtransillumination and radiofrequency cutting and coagulation.

As shown in FIG. 11 , in another embodiment, the treatment system 940includes a handle 942 and an elongate member 944 extending from thehandle. A shaft or wire (not shown) configured within the elongatemember 944 is attached to a treatment device 925 and alternatively oradditionally, a rotatable trigger 946 is attached at a lower, distalportion of the handle 942. Configured within the handle 942 is a slider947 that is attached to the shaft or wire and is associated andcooperates with the trigger 946. A constant force spring 950 isassociated and cooperates with the slider 947 to retract cuttingstructure of the treatment device 925 when the trigger 946 is released.Further, transillumination structure is configured within the handle 942and includes a battery compartment 952 and an electrical switch 954 forturning on and off a light source (e.g. LED) configured at a distal endof the treatment system 940.

Pulling the trigger 946 completely results in configuring a treatmentdevice 925 into a hooking configuration where cutting structure of thetreatment device 925 is protected. Upon releasing the trigger 946slightly, the spring 950 retracts the shaft or wire associated with thetreatment device 925, and positions the shaft or wire within a detent onthe slider 947 to signal the user with a tactile feedback that thecutting structure of the treatment device 925 is exposed. Full releaseof the trigger 946 results in the spring 950 retracting the shaft orwire completely to thereby place the treatment device 925 in a closed orundeployed position. The treatment system 940 can then be re-positionedand manipulated again to treat additional areas.

Various additional embodiments of treatment devices are described inFIGS. 12A-18C. With reference to FIGS. 12A-C, the cutting, slicing ordisrupting treatment assembly is again defined by a projecting linkagearrangement. A first link 1400 includes a blade 1401 and is rotatablyattached at one end to a second link 1402. The opposite end of the firstlink 1400 slides with respect to a longitudinal shaft 1405 (shown as atleast partially transparent). The shaft 1405 defines a housing forsupporting and containing the linkage arrangement. A second end of thesecond link 1402 is rotationally affixed to a distal point on the shaft1405. A drive shaft or push rod 1407 is rotatably or pivotably attachedto the opposite end of the first link 1400 and the second link 1402includes a generally triangular or pointed projection 1408 that is sizedand shaped to shield the blade 1401 from contacting tissue when theassembly is placed in a hooking configuration. When the push rod 1407 isfully retracted (FIG. 12A), the blade 1401 is sheathed within the bodyof the longitudinal shaft 1405. It is noted that in the fully retractedconfiguration that the first and second links 1400, 1401 form an obtuseangle and the projection 1408 extends a relatively small distance froman opposite side of the longitudinal shaft. When the push rod 1407 isadvanced completely to a stop, the projection 1408 contacts the push rod1407 and the blade 1401 is again protected by the projection 1408 (FIG.12B). It is in this configuration that the treatment device can be usedto hook target septa and to test septa to determine if such septa isassociated with the expression of cellulite on a patient's skin.Withdrawing the push rod 1407 from its fully advanced position and onthe order of about 0.070 inches in one embodiment (See FIG. 12C wherethe blade 1401 is shown transparent for illustrative purposes), theblade 1401 is exposed and presented for engaging and cutting, slicing ordisrupting target septa. The treatment device also has a blunt,atraumatic tip 1406 that allows the treatment device to be advancedthrough the subcutaneous tissue with little trauma. In all embodiments,blunt tip 1406 can house a light emitting diode, be a light emittingdiode or house the end of a light fiber in order to facilitatetransillumination through the skin for the user to use for guidance inknowing the location of the tip of the treatment device.

It is to be recognized that additionally or alternatively, the tip inany of the disclosed embodiments can be shaped so as to be characterizedby or associated with a low introduction and advancement force throughand within the patient's skin and anatomy, while also presenting a lowlikelihood of damaging tissue. Accordingly, the tip can assume bulletpoint or short dilator tip shapes, or can define a sharp profile or atrocar-type configuration for ease of advancement or tracking.Additionally, the tip can be retractable, reconfigurable or otherwisedefine a sharpened structure only when the tip is presented with apre-determined level of resistance. In one particular approach, a springloaded cover or shield is configured about the tip such that whenpresented with a defined resistance, the cover or shield is removed toexpose a sharpened tip configured to facilitate advancement of thetreatment device or reduce the force to cross patient anatomy.

In an alternative approach (FIGS. 13A-D). the second link 1402 includesa blade 1401 that has a sharpened protrusion 1403, and the first link1400 functions as a blocker to shield a main portion of the blade 1401from contacting tissue when the treatment device is in the hookingconfiguration. When the treatment device is in the hooked configuration,the sharpened protrusion 1403 extends proximally from the pivot betweenthe first link 1400 and second link 1402 so that as the treatment deviceis pulled proximally by the user, the pivot location, as the leadingportion of the device during retraction, does not get snagged in tissuebut rather slices through it so the user can hook and feel resistance ofsepta with the main portion of the first link 1400. Notably, in a fullyretracted position (FIG. 13A), the first and second links 1400, 1401define an obtuse angle and when the push rod 1407 is advanced nearlycompletely (FIG. 13B), a majority of the blade 1401 is protected by thesecond link 1402. As such, structure is presented in a hook-form both toencourage hook capture as well as provide a portion of unprotected blade1403 near the connection between the first and second 1400, 1402 links.Completely advancing the push rod 1407 fully exposes the blade 1401 forcutting, slicing or disrupting target septa (See FIGS. 13C-D; FIG. 13Dshowing the first blade as transparent for illustrative purposes) as thetreatment device is retracted proximally by the user.

In employing one or more of the disclosed embodiments in a treatmentprocedure, there is an expectation that there are instances where it ispreferable to not disrupt a hooked septa, and in such a case it isdesirable to release or disengage the hooked septa. In certainapproaches, to release or disengage, the treatment device would beadvanced or twisted away from the hooked septa. It is thus recognizedthat a challenge exists in that there may be additional septa or othertissue in the area which could be unintentionally re-engaged by thetreatment device when it is in a hooking configuration, and stowing ofthe treatment device may be inhibited by adjacent patient anatomy. Withreference to FIGS. 13E-F, treatment devices that include a hinge linkarrangement 1400, 1402 or similar structure that transition from ahooked configuration (FIG. 13E) toward a stowed configuration (FIG. 13F)by pivoting relative to the longitudinal shaft 1405, benefit from theblocking link 1400 (or similar structure) moving to push septa 350 orother tissue away from the treatment device as the treatment device isbeing sheathed or stowed. This action requires no additional advancementof the treatment device within patient anatomy and ensures that septa350 or other tissue do not become undesirably entrapped. Moreover, whenbeing stowed the links 1400, 1402 dislodge any tissue that might havebecome captured within the longitudinal shaft 1405 and the links 1400,1402 ultimately occupy such spaces within the longitudinal shaft 1405.

Turning now to FIGS. 14A-F, there is shown yet another approach to atreatment device. Here, there are provided two parallel arranged andarticulating first links 1420, 1422 arranged to block or shield a blade1401 attached to or forming an edge of a second link 1402. The firstlinks 1420, 1422 each define a curved or yoke-shaped member with aunique profile designed to selectively shield the second link 1402, afirst end 1424 of each rotatably or pivotably attached to a pusher 1407and second ends 1426 rotatably or pivotably attached to the second link1402. The parallel arranged first links 1420, 1422 provide additionalstrength for the hooking and cutting positions. When the push rod 1407is fully retracted (FIGS. 14A and 14D), a curved portion of the firstlinks 1420, 1422 projects from an opposite side of the longitudinalshaft 1405 (shown at least partially transparent) from which the linksextend when deployed for hooking or cutting, slicing or disruptingsepta. To present tissue hooking structure, the push rod 1407 isadvanced so that the first links 1420, 1422 completely shield or blockthe blade 1401 (See FIGS. 14B and 14E; one first link 1420 is shown astransparent for illustrative purposes in FIG. 14E) from contactingtissue. Advancing the push rod 1405 completely operates to fully exposethe blade 1401 (See FIGS. 14C and 14F) and thus present the blade 1401for cutting, slicing or disrupting target tissue.

As shown in FIGS. 15A-F, a treatment device can alternatively oradditionally include first and second push rods 1430, 1432, the firstpush rod 1430 configured to manipulate an articulating or pivoting firstlink 1434 and the second push rod 1432 configured to manipulate anarticulating or pivoting second link 1436 that includes a blade 1401surface. When the push rods 1430, 1432 are in a fully advanced position(FIGS. 15A and 15D), the first 1434 and second 1436 links are generallyparallel and stowed within the longitudinal shaft 1405 (shown at leastpartially transparent). Withdrawing the push rods 1430, 1432 operate toproject the first 1434 and second 1436 links from the stowed position(See FIGS. 15B, C, E, F). Withdrawing the push rods equally results inthe first link 1436 overlaying yet fully exposing the blade 1401 (FIGS.15C and 15F) for cutting, slicing or disrupting target tissue, but whenthe push rod 1430 associated with the first link 1434 is advanced to adifferent degree than the second push rod 1432, a portion of the blade1401 can be shielded or blocked by the first link 1434 (FIG. 15B)thereby presenting structure for hooking target tissue, or a portion ofthe blade 1401 can be shielded (FIG. 15E) thus presenting both hookingand cutting structures. This embodiment could also have blunt tip 1406.

In additional or alternative aspects, the robustness of the blademechanism of a treatment device can be enhanced by strengthening pivotpoints, increasing strength of the longitudinal shaft and improvingblade concealment during insertion and advancement within and hooking oftissue. As shown in FIG. 16A, a welded pin or swaged tube 1450 can beused at the connection between first 1400 and second link or links 1402.Also, mechanical joining such as a welded pin or swaged tube can formthe connection between second link or links 1402 and a distal portion ofthe longitudinal shaft 1405. Such pivot points can in one or moreembodiments be defined by about 0.025 inch diameter pins or tubes, forexample, and can be used at one or more rotating or pivoting connectionsof a treatment system. Moreover, as best seen in FIGS. 16B-C, a firstlink 1400 including a blade 1401 can be configured between a pair ofsecond links 1402 (one link shown as transparent) rather than concealedby or cooperating with a single first link 1400.

As shown in FIGS. 17A-C, in an alternative or additional approach, atreatment system lacks projecting structure when the links 1400, 1402are fully retracted and housed within the longitudinal shaft 1405 (FIG.17A). The first link 1400 acting as a blocking or blunt element can bespring loaded so that it shields the blade 1401 formed on the secondlink 1402 (FIG. 17B) until a critical force is achieved and then theblade 1401 is presented (FIG. 17C) for cutting, slicing or disruptingtarget septa. After cutting or slicing, the blade 1401 can be configuredto automatically be re-sheathed or an actuator such as a button can beprovided to re-sheath the blade 1401. In such approaches, there is twopositions of the links, namely sheathed and deployed. The same reducesthe overall force requirements since there is not a condition where auser employs the hooking structure at too high of a force. Thus, theblade 1401 is fully sheathed or contained within the longitudinal shaft1405 during navigation, and deployed when necessary. In this way, thelongitudinal shaft 1405 can be formed from a hypotube for example, withfewer cuts for ejecting and storing the links 1400, 1402. Such structureor related functionality can be incorporated into any of the disclosedembodiments to thus provide spring-loaded cutting to require a certain,controlled amount of force to expose the blade for cutting. Thisembodiment could also have blunt tip 1406.

In a related approach (See FIG. 18A-C), the blocking or hooking functionis provided by a pair of curved or angled first links 1400. In a stowedconfiguration, the curved or angled links 1400 project from an oppositeside of the longitudinal shaft 1405 from the deployed or treatment sideof the shaft 1405 (FIG. 18A). However, like the immediately precedingapproach, the blocking or shielding first links 1400 are spring loadedso that they reside on opposite sides and shield the blade 1401 (FIG.18B) until a critical force is achieved and then the blade is exposed(FIG. 18C) for cutting, slicing or disrupting target septa. Again here,after cutting or slicing, the blade 1401 can be configured toautomatically be re-sheathed or an actuator such as a button can beprovided to re-sheath the blade 1401, and there is two positions of thelinks, namely sheathed and deployed.

With reference now to FIGS. 19A-B, there is shown a handle 1922 of atreatment device that includes a trigger or slider assembly 1926 thatincludes a depressible button 1928. The handle 1922 includes a track1929 along which the button 1928 is registered. Such an arrangement canbe incorporated into one or more of the previously disclosed treatmentsystems. As shown in FIG. 19A, the button 1928, in one embodiment, isbiased relative to the track 1929 by a helical spring 1930. The sliderassembly 1926 is attached to a drive shaft or pusher 1407 that isconnected to and facilitates manipulation of a treatment device (notshown). The button 1928 is depressible to release a locking or otherengagement between the button 1928 and the track 1929 so that the sliderassembly 1926 can be slid relative to the handle 1922. Releasing thebutton 1928 results in allowing the button to engage the track 1929 andslide into locking engagement with one of a series of cut-outs 1932formed in the track 1929. It is to be noted that when not locked to thetrack 1929, the button 1928 of slider assembly can engage and slidealong the track 1929 between locking positions. Such cut-outs 1932 arearranged and located so that when the slider assembly 1926 is locked tothe track 1929, the treatment device is positioned in one or more ofsheathed, hooking or cutting positions within tissue and relative totarget septa. A secure engagement between the slider assembly 1926 andthe handle 1922 is thus provided as is tactile feel to the userconcerning the positioning and state or configuration of the treatmentdevice. As shown in FIG. 19B, rather than a helical spring, the button1930 is biased by a leaf spring 1934. Also, here, the button 1928 isconfigured to be separately actuatable and defines an independentlydepressible structure from the sliding structure of the slider assembly1926 to thereby provide alternative discrete control of sliding andlocking functions.

Further approaches to treatment systems are depicted in FIGS. 20A-22C.As shown in FIGS. 20A-C, a treatment system 1940 includes a handleassembly 1942 that includes a slider 1943 biased by a spring 1944, theslider 1943 is configured to be translated along a portion of a body1946 of the handle assembly 1942. A button 1947 projects vertically froman upper surface of the slider 1943, the button 1947 being connected toor associated with a boss 1948 that rides within a slot formed in theslider 1942. The boss 1948 also slides along and is configured to beregistered along a ramp 1949 or other engaging structure formed withinthe handle body 1946. Also, rotatably attached to the slider 1943 is alever 1950 that includes a curved slot 1951 that receives a boss 1952projecting from a bracket 1953. Each of the slider 1943 and the bracket1953 are attached to one or more longitudinally extending members 1954that is/are associated with a treatment device 1956 attached at aterminal end portion thereof (See FIGS. 20D-F). Attached to the proximalend of the handle assembly 1942 is an optional light and energy sourceunit 1995, for example, a light emitting diode and battery. Extendingdistally through the handle assembly 1942 and longitudinal shaft of thetreatment device 1956 to the distal portion of the longitudinal shaft isa light fiber (not shown) to transmit light from the light and energysource unit 1995 to the distal portion of the treatment device 1956 toprovide transillumination through the skin for the user.

In a treatment device stowed position (See FIGS. 20A and D), the slider1943 is in its most proximal position and the spring 1944 is mostlycompressed. As the slider 1943 is translated forward (FIGS. 20B and E),the spring 1944 is extended and the slider boss 1948 becomes temporarilyand fixedly registered along the ramp 1949. Due to this action, thelongitudinally extending member 1954 is advanced to manipulate thetreatment device 1956. It is in this configuration that the treatmentdevice 1956 is in a deployed but covered configuration intended forhooking or otherwise engaging target septa. By subsequently depressingthe rotatable lever 1950, through the interaction of the lever 1950 andthe bracket 1953, the longitudinally extending member 1956 is advancedslightly further in a distal direction to uncover a treatment devicesharpened link or blade 1957 (See FIGS. 20C and F), the sharpened linkor blade 1957 being configured for cutting, slicing or disrupting septa.Notably, a spring (not shown) is configured between the lever 1950 andbracket 1953 to bias the lever 1950 to return the treatment device 1956to a locked and hook configuration. After desired manipulation of thetreatment device 1956 at an interventional site, the slider button 1947is depressed to release the engagement between the slider boss 1948 andthe ramp 1949 to thereby permit the spring 1944 to return the slider1943 to its most proximal position and to stow away the treatment device1956 for further use or removal from the interventional site. Inalternative approach, the system 1940 would lack the lever 1950 and anadditional spring (not shown) is configured to only allow advancement ofthe bracket 1953 when the treatment device 1956 is presented with apre-determined resistance, at which time the blade 1957 is permitted tobe exposed. In this way, the tool is more easy to use and the cuttingstep subsequent to hooking septa is less likely to be omitted.

In another approach (FIGS. 21A-C), the treatment system 1960 includes ahandle assembly 1962 that includes a slider 1963 biased by a spring1964, the slider 1963 also being configured to be translated along aportion of a body 1966 of the handle assembly 1962. Here, rather thanproviding a button to unlock the slider 1963, the slider 1963 isconfigured to rotate with respect to the body 1966 and the slider 1963itself includes a boss 1968 that slides along and is configured to beregistered along a ramp 1969 or other engaging structure formed withinthe handle body 1966. Also, here, rotatably attached to the slider 1962is a lever 1970 that includes a curved slot 1971 that receives a boss1972 projecting from a bracket 1973. Each of the slider 1962 and thebracket 1973 are attached to one or more longitudinally extendingmembers 1976 that is/are associated with a treatment device attached ata terminal end portion thereof (Not shown, but for example like thestructures depicted in FIGS. 20D-F).

When a treatment device is in a stowed position (See FIGS. 21A), theslider 1962 is in its most proximal position and the spring 1964 ismostly compressed. As the slider 1962 is translated forward (FIG. 21B),the spring 1964 is extended and the slider boss 1968 becomes temporarilyand fixedly registered along the ramp 1969, and the longitudinallyextending member 1976 is advanced to manipulate the treatment device. Itis in this configuration that the treatment device is in a deployed butcovered configuration intended for hooking or otherwise engaging targetsepta. Thereafter, by depressing the rotatable lever 1970, through theinteraction of the lever 1970 and the bracket 1973, the longitudinallyextending member 1976 is advanced slightly further in a distal directionto uncover a treatment device sharpened link or blade (See FIG. 21C). Inthis configuration, the treatment device is configured to cut, slice ordisrupt target septa. A spring (not shown) is configured between thelever 1970 and bracket 1973 to bias the lever 1970 to return thetreatment device to a locked and hook configuration. After desiredmanipulation of the treatment device at an interventional site, theslider 1962 is depressed and rotated to release the engagement betweenthe slider boss 1968 and the ramp 1969 to thereby permit the spring 1964to return the slider 1962 to its most proximal position and to stow awaythe treatment device.

As shown in FIGS. 22A-C, the treatment device 1980 can additionally oralternatively include a handle assembly 1982 that includes a slider 1984configured to slide along a body of the handle assembly 1982. When theslider 1984 is in its most proximal position (FIG. 22A), the treatmentdevice (not shown) is in a stowed position. The slider 1984 is attachedto a pair of rotatable, angled members 1986, 1987, the ends of each ofwhich are rotatably attached to the the handle body and to the slider1984, respectively. The forwardly positioned rotatable member 1986further includes an extension 1988 that is rotatably attached to arotatable bracket 1989 that is in turn rotatably attached to alongitudinally extending member 1990 that has a treatment device (notshown) attached to a distal end portion thereof. A button 1992 projectsvertically from the slider 1984 and the button 1992 is associated with aboss 1993 that is configured to be registered along a portion of thebody of the handle assembly 1982 (See FIG. 22B). When so positioned withthe slider 1984 advanced along the handle body and the boss 1993registered within a recess 1994 formed in the handle body, the treatmentdevice is deployed but covered at least partially to present structurefor hooking or engaging target septa. By depressing the button 1992, theboss 1993 of the slider 1984 can be disengaged from the recess 1994 tothereby permit the slider 1992 to be advanced further distally. In doingso, the longitudinally extending member 1990 can be advanced further toexpose a cutting portion of a treatment device for cutting, slicing orengaging tissue and accomplishing desired interventional treatments. Theslider 1992 can then be returned to either of the stowed or deployed butcovered positions as desired for further interventional steps.Accordingly, this approach provides a mechanism that scales up smallmovements of the handle assembly so that the configuration of thetreatment device (e.g., contained, hook or cut positions) is made moreobvious to the user.

In the previous embodiments described, a “ball point pen” type ofmechanism can be used in the handle assembly such that after the hookand/or sharpened edge have torn or cut through septa, the linkageautomatically restows upon a sudden reduction in force on the linkage asit tears or cuts through the septa.

In another embodiment, a coil is deployed from the distal portion of thetreatment device and rotated to wind the septa into the coil tore-create the targeted cellulite on the skin surface, then the coil ispulled by the user to disrupt or cut the septa or a cutter is used tosever the septa.

Accordingly, various approaches to cellulite treatment methods andapparatus are presented. The disclosed approaches are configured toprovide an effective and focused approach to treating, minimizing andpreventing cellulite. The disclosed approaches can also be used torepair and reduce the appearance of cellulite in a targeted manner.Further, the disclosed proactive treatment modalities are easy andeffective to use.

Some of the specific aspects of the present disclosure include one ormore of focal treatment of just the septa responsible for causingdimples or depressions in the skin; minimizing bruising; accessing alltreatment targets from limited, cosmetically acceptable entries; captureand retention of septa while separating the septa; intra-operativeconfirmation of treated target; needle-diameter sized tools for smallopenings; and transillumination identification of tool tip location.

While the present disclosure has been described with reference to thespecific embodiments thereof, it should be understood by those skilledin the art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of thedisclosure. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processstep or steps, to the objective, spirit and scope of the presentdisclosure. All such modifications are intended to be within the scopeof the present disclosure.

That which is claimed is:
 1. A cellulite treatment apparatus fortreating expressions of cellulite on a patient's skin associated with asepta treatment site, comprising: a handle; a shaft longitudinallyextending from the handle, the shaft sized and shaped to be insertedwithin tissue and to be advanced between tissue layers to the septatreatment site without assistance from tissue stabilizing structureapplied to the patient's skin; and a septa engaging assembly at a distalportion of the shaft; an actuator on the handle to actuate the septaengaging assembly, wherein the actuator positions the septa engagingassembly in at least a retracted position, a septa tensioning positionwhere the septa engaging assembly is positioned to apply tension tosepta in a direction parallel to the shaft, and a septa disruptionposition.
 2. The cellulite treatment apparatus of claim 1, furthercomprising a transillumination structure.
 3. The apparatus of claim 2,wherein the transillumination structure is embodied in a lightpositioned along a distal portion of the shaft.
 4. The apparatus ofclaim 3, wherein the light is one or more of a LED or a lightguide. 5.The apparatus of claim 1, wherein the septa engaging and cuttingassembly includes a side opening hook.
 6. The apparatus claim 1, whereinthe septa engaging and cutting assembly includes laterally projectinglinkages.
 7. The apparatus claim 1, wherein the septa engaging andcutting assembly includes selective cautery structure or energytransmitting structure.
 8. The apparatus claim 1, wherein the septaengaging assembly is sized and shaped to test septa to determine whethertested septa is associated with an expression of cellulite and tostretch, cut, slice or otherwise disrupt septa associated with theexpression of cellulite.
 9. The apparatus of claim 1, wherein the septaengaging assembly comprises a first link rotatably attached to a secondlink and a drive shaft attached to the first link, the first link,second link and drive draft being contained within a longitudinal shaft,wherein manipulation of the drive shaft causes the first link and secondlink to project laterally from the shaft.